A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors And in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

This study is currently recruiting participants.
Verified January 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01296555
First received: February 14, 2011
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0032 administered every day orally (PO).


Condition Intervention Phase
Solid Cancers
Drug: GDC-0032
Drug: letrozole
Drug: fulvestrant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Incidence of adverse events by NCI CTCAE v4.0 grade and associated dose of GDC-0032 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Incidence of dose-limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0032 [ Time Frame: Days 1-35 ] [ Designated as safety issue: No ]
  • Incidence of Grade 3 and 4 abnormalities in safety related laboratory parameters and associated dose of GDC-0032 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Safety in combination with letrozole: incidence of adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Safety in combination with fulvestrant: Incidence of adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best overall response for patients with measurable disease according to RECIST v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Duration of objective response for patients with measurable disease according to RECIST v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) for patients with measurable disease according to RECIST v1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 122
Study Start Date: March 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-Agent Cohorts Drug: GDC-0032
Oral repeating dose
Experimental: Combination expansion cohorts Drug: GDC-0032
Oral repeating dose
Drug: letrozole
Repeating dose
Drug: fulvestrant
Repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit
  • Evaluable or measurable disease per RECIST v1.1
  • Life expectancy of >= 12 weeks
  • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
  • Documented willingness to use an effective means of contraception for both men and women while participating in the study

Exclusion Criteria:

  • Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for >= 3 months prior to initiation of study treatment
  • Type 1 or 2 diabetes requiring daily anti-hyperglycemic medication
  • Grade >=2 peripheral neuropathy
  • Active congestive heart failure or ventricular arrhythmia requiring medication
  • Patients requiring any daily supplemental oxygen
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
  • Treatment with chemotherapy <= 4 weeks before study treatment
  • Treatment with investigational drug <= 4 weeks before study treatment
  • Treatment with biologic therapy <= 4 weeks before study treatment
  • Treatment with kinase inhibitors <= 2 weeks before study treatment
  • Radiation therapy <= 4 weeks before study treatment
  • Radiation therapy for bony metastases <= 2 weeks before study treatment; other radiation for cancer therapy <= 4 weeks before study treatment
  • Major surgery <= 4 weeks before study treatment
  • Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the patients at high risk from treatment complications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296555

Contacts
Contact: Please reference Study ID Number: PMT4979g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
United States, Arizona
Recruiting
Scottsdale, Arizona, United States, 85258
United States, Florida
Recruiting
Sarasota, Florida, United States, 34232
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02115
Recruiting
Boston, Massachusetts, United States, 02114
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37203
Recruiting
Nashville, Tennessee, United States, 37232
Recruiting
Nashville, Tennessee, United States, 37204
Spain
Recruiting
Barcelona, Spain, 08035
Recruiting
Valencia, Spain, 46010
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01296555     History of Changes
Other Study ID Numbers: PMT4979g, GO00886
Study First Received: February 14, 2011
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013